An observational study in Osteoarthritis, Osteoporosis and Osteogenesis Imperfecta, sponsored by University College, London. Active, not recruiting. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by University College, London · Observational
In this study spatially offset Raman spectroscopy (SORS), which allows the collection of Raman spectra through turbid media, is being applied to collect Raman spectra of bone. The principal aim to find ways to use Raman spectroscopy to assess bone quality in vivo.
Control patients, patients with osteoarthritis, patients with osteoporosis, patients with osteogenesis imperfecta, patients with rickets or osteomalacia, patients with suspected bone infection.
INCLUSION CRITERIA
Cohort 1: 40 volunteers, free from bone disease:
Cohort 2: 40 patients with OI:
Cohort 3: 40 patients with OA:
Cohort 4: 40 patients with OI, receiving treatment with bisphosphonates:
Cohort 5: 2x 30 patients with OP (two treatment groups):
Cohort 6: 10-15 participants with rickets, 10-15 participants with osteomalacia
Cohort 7: 5 participants with a suspected bone infection
EXCLUSION CRITERIA In general smokers will be excluded. Ex-smokers will be included only if they gave up smoking a minimum of 5 years ago.
Cohort 1: 40 volunteers, free from bone disease:
Cohort 2: 40 patients with OI; Cohort 3: 40 patients with OA; Cohort 6: 20 patients with rickets/osteomalacia • Patients with more than 1 type of bone disease
Cohorts 4, 5 and 6: receiving treatment
40 volunteers free from bone disease. No family histroy of osteogenesis imperfecta (OI). No history of non-accidental fracture. No history of osteoarthritis (OA) or clinical manifestations of disease. No clinical features of OI, OA or osteoporosis (OP). Normal haemoatology and biochemical blood screen. Controls will be gender and age matched (within five years) to the disease cohort patients. Children and adults both required.
Device: spatially offset Raman spectrometer (SORS)
40 patients with OI. Patients must have been clinically diagnosed with OI. Participants will be identified form the Royal National Orthopaedic Hospital, Metabolic Unit database. Bone mineral density (BMD) confirmed with DXA.
Device: spatially offset Raman spectrometer (SORS)
40 patients with OA. Patients must have been clinically diagnosed with OA. Participants will be identified from the Royal National Orthopaedic Hospital, Metabolic Unit database.
Device: spatially offset Raman spectrometer (SORS)
40 patients with OI receiving treatment with bisphosphonates. Patients must have been clinically diagnosed with OI and bisphosphonates prescribed as a course of treatment. 20 Adults and 20 Children. Where possible participants will be identified from the Royal National Orthopaedic Hospital (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed.
Device: spatially offset Raman spectrometer (SORS)
Patients must have been clinically diagnosed with OP. The first group will have been prescribed with bisphosphonate anti-resorptive treatment; the second with anabolic agents. Where possible participants will be identified from the Royal National Orthopaedic Hospital (RNOH), Metabolic Unit Database; if not from the RNOH then diagnosis will be otherwise confirmed. Bone mineral density (BMD) will be confirmed with DXA. Where possible measurements will be acquired prior to the start of treatment and then up to 4 follow up visits at flexible time points to allow scheduling to coincide with hospital appointments. Minimum time between vistis should be 2 months.
Device: spatially offset Raman spectrometer (SORS)
10-15 participants with rickets and 10-15 participants with osteomalacia. Patients must have been clinically diagnosed with rickets/osteomalacia. Blood tests for 25-hydroxyvitamin D should be less than or equal to 25 nmol/L. Once participants are on treatment further measurements will be made 6 months afterwards. Participants for rickets and osteomalacia groups will be recruited to give a total of 10 complete sets of data per group.
Device: spatially offset Raman spectrometer (SORS)
Participants will have been diagnosed at RNOH with a suspected bone infection. Participants will be scanned around the localised area of suspected infection. Participants may have 1 or 2 vists; the latter to take place after all infection has cleared up. This is not subject to a fixed time frame.
Device: spatially offset Raman spectrometer (SORS)
Raman spectra will be collected non-invasively from patients using a lower power 830 nm laser. A probe is brought into gentle contact with the patients skin and measurements taken. The laser power has a pre-defined safe threshold of 30 mW into a 3.5 mm diameter aperture. Built in device safety features prevent this threshold from being exceeded. The probe that comes into patient contact is suitable for disinfecting.
SORS Raman spectral fingerprint for bone disease types and changes over time
Individual patient data will be pre-processed and extracted after patient participation visits. As cohorts are filled multivariate classification models will be built to validate disease discrimination and validation of the SORS technique.
Time frame: SORS Raman spectral features will be evaluated using a variety of multi-variate analytical tools e.g. BTEM at time zero and a repeat measure within a year.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University College, London